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Ablation Index in Standard vs. High Power Radiofrequency Ablation for Typical Atrial Flutter: A Randomized Study (AITAF) - Trial NCT06406686

Access comprehensive clinical trial information for NCT06406686 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Calgary and is currently Not yet recruiting. The study focuses on Atrial Flutter,Atrial Flutter Typical,Cavotricuspid Isthmus Dependent Macroreentry Tachycardia. Target enrollment is 50 participants.

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NCT06406686
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Trial Details
ClinicalTrials.gov โ€ข NCT06406686
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Ablation Index in Standard vs. High Power Radiofrequency Ablation for Typical Atrial Flutter: A Randomized Study (AITAF)

Study Focus

Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter

Interventional

procedure

Sponsor & Location

University of Calgary

Calgary, Canada

Timeline & Enrollment

N/A

Jun 03, 2024

Jun 03, 2025

50 participants

Primary Outcome

RF time to durable CTI block

Summary

A randomized controlled trial will be conducted to evaluate the efficacy of Ablation
 Index-guided high power - short duration (HPSD) ablation compared to conventional power
 settings in Cavotricuspid Isthmus (CTI) dependent atrial flutter. Participants will be
 randomized to receive either AI-guided HPSD ablation at 50 Watts or conventional power
 settings at 30 Watts. Both arms will use the Carto 3D mapping system and the QDOT MICRO
 ablation catheter (Biosense Webster). An anatomically contiguous line will be created with
 6mm inter-lesion distance. After a standardized wait time of 30 minutes, ablation success
 will be assessed. The primary outcome is total radiofrequency ablation time. Secondary
 outcomes include procedural time, fluoroscopy time, safety outcomes, and 3-month freedom from
 recurrence. It is our expectation that HPSD will result in a shorter primary outcome.

ICD-10 Classifications

Atypical atrial flutter
Typical atrial flutter
Atrial fibrillation and atrial flutter, unspecified
Atrial fibrillation and flutter
Tachycardia, unspecified

Data Source

ClinicalTrials.gov

NCT06406686

Non-Device Trial